Valsalva mask

ABSTRACT

An interface for positive pressure therapy includes a mask assembly and a headgear assembly. The mask assembly comprises a mask seal that is adapted to underlie the nose. The mask seal extends up the lateral sides of the nose. The mask seal has a primary seal below the nose and a secondary seal alongside the nose.

BACKGROUND OF THE INVENTION Field of the Inventions

The present inventions generally relate to face masks that cover atleast one of a nose and a mouth of a user to supply respiratory gasunder positive pressure. More particularly, certain aspects of thepresent inventions relate to such masks that have an improved nasal sealportion.

Description of the Related Art

Face masks can be used to provide respiratory gases to a user underpositive pressure. In configurations in which both a mouth and a nose ofa user are covered, the full face mask typically will overlie a bridgeof the nose. Generally, a single seal will circumscribe the nose and themouth of the user.

Such full face masks commonly are secured to a head of the user withheadgear. In order to sufficiently reduce leakage, the headgeartypically is tightened, which results in an elevated pressure beingexerted on a bridge of a user's nose. As the headgear is tightened, theseal typically applies a progressively increasing load on the bridge ofthe nose. The pressure can be a source of discomfort and, in somecircumstances, can lead to pressure sores over time. Looser fittingheadgear may provide greater patient comfort, but air leakage can occur.In particular, loose fitting and in some cases even tight fitting maskscan leak air around the portion of the mask near the user's tear ductsand nasal bridge.

SUMMARY OF THE INVENTIONS

It is an object of the present disclosure to provide one or moreconstructions and/or methods that will at least go some way towardsimproving on the above or that will at least provide the public or themedical profession with a useful choice.

Accordingly, an interface is provided for use in providing positivepressure respiratory therapy. The interface comprises a mask assembly.The mask assembly comprises a mask seal, a mask base that can beremovably or permanently connected to the mask seal, and a sealadjustment mechanism. The seal adjustment mechanism can provide andcontrol a lateral force to compress the seal against the user's nasalbone without applying additional pressure to the user's nasal bridge. Insome configurations, the mask assembly may further comprise a headgearassembly. A connection port assembly may also be provided independently,attached to, or integrated with the mask base.

In one configuration an interface for use in providing positive pressurerespiratory therapy comprises: a mask assembly comprising a mask sealand a mask base that is removably connected to the mask seal; a sealadjustment mechanism coupled to the mask base and configured to compressthe mask seal primarily in a lateral direction across a width of themask assembly; a headgear assembly comprising a pair of upper straps anda pair of lower straps, one of the pair of upper straps and one of thepair of lower straps being connected to a first clip, another of thepair of upper straps and another of the pair of lower straps beingconnected to a second clip, the first clip and the second clip beingdetachably securable to the mask base such that the clips are broughtinto engagement with the mask base by moving in a directionsubstantially normal to a strap tensile force direction; and aconnection port assembly comprising an elbow terminating in a ballshaped member, the ball shaped member being sized and configured to beheld within a wall of the mask base.

In one configuration, a mask assembly comprising a mask seal, the maskseal, a mask base, and a mask seal adjustment mechanism, the mask sealadjustment mechanism configured to adjust the distance between oppositewalls of the mask seal. In one configuration, the mask seal adjustmentmechanism comprises a dial coupled to a screw and a cage, the screwpositioned within a thread of a cage, the cage having two arms thatcontact the mask seal, wherein rotating the dial causes the cage to movetowards the mask base and squeeze the seal inwardly to decrease thedistance between the opposite walls of the mask seal engaged by thecage. In one configuration, the cage defines a cavity and the mask sealis positioned at least partially within the cavity.

In one configuration, the mask seal adjustment mechanism comprises aswing arm pivotably coupled to the mask base, the swing arm comprising alift bar and first and second ends, wherein lifting the lift bar lowersthe first and second ends to compress opposite walls of the mask sealand to decrease a distance between the opposite walls of the mask seal.

In one configuration, the swing arm further comprises first and secondpads attached to the first and second ends, respectively, the first andsecond pads configured to contact and squeeze opposite walls of the maskseal when the lift bar is raised.

In one configuration, the mask seal adjustment mechanism furthercomprises a ratchet configured to retain the lift bar in a desiredposition with respect to the mask base. In one configuration, the maskseal adjustment mechanism further comprises a dial and cog configured toretain the lift bar in a desired position with respect to the mask base.In one configuration, the mask seal adjustment mechanism comprises amalleable strip that is fixed to the mask seal. In one configuration,the malleable strip is fixed to the mask seal at the malleable stripsend regions.

In one configuration, the mask seal adjustment mechanism comprises aT-piece swing arm coupled to the mask base at first and second pivots,the T-piece swing arm comprising a laterally-extending sectionconfigured to attach to a headgear assembly and a two compression armpositioned closer to the pivots than the laterally-extending section,the compression arms extending posteriorly towards the mask seal,wherein tension applied to the laterally-extending section rotates theT-piece swing arm about the pivots and causes the compression arms tosqueeze and decrease the distance between opposite sides of the maskseal.

In one configuration, the mask seal adjustment mechanism comprises adrum vice, the drum vice comprising a finger wheel, a screw coupled tothe finger wheel, and compression arms attached to opposite ends of thescrew, wherein rotating the finger wheel rotates the screw which turnswithin a thread of the compression arms and moves the compression armstowards each other, wherein the moving compression arms compress anddecrease the distance between opposite sides of the mask seal. In oneconfiguration, the screw comprises a double threaded screw.

In one configuration, the mask seal adjustment mechanism comprises adial, a cam coupled to the dial, and two rocker arms pivotably attachedto the mask base, wherein turning the dial rotates the cam and causesthe cam to lift first ends of the rocker arms, the rocker arms beingsubstantially L-shaped such that as the cam lifts the first ends of therocker arms, second ends of the rocker arms drum compress and decreasethe distance between opposite sides of the mask seal.

In one configuration, the mask seal adjustment mechanism comprises adial having a geared surface, a screw having a screw head configured toengage the geared surface and a threaded shaft, two paddles, the paddlescomprising gear teeth at one end and configured to engage the threadedshaft, the paddles further comprising arms that extend to compressionends, wherein rotating the dial about a first axis turns the screw abouta second axis, the second axis being perpendicular to the first axis,and wherein the screw rotates the paddles about third and fourth axes,the third and fourth axes being parallel to each other and the firstaxis, wherein rotating the paddles moves the arms and compression endstowards each other and decreases the distance between opposite sides ofthe mask seal between the compression ends.

In one configuration, the mask seal adjustment mechanism comprises: adial positioned within a threaded opening in the mask base and having anexternal thread and an internal, tapered channel; and two compressionarms having posteriorly-projection portions that extend into the taperedchannel and anteriorly-projecting portions that extend along oppositesides of the mask seal, wherein rotating the dial within geared surfacemoves the two compressions arms towards each other and decreases thedistance between opposite sides of the mask seal between theposteriorly-projecting portions.

In one configuration, the mask seal adjustment mechanism comprises twoscissor arms that pinch opposite sides of the mask seal when the armsare rotated with respect to each other, wherein rotating the arms withrespect to each other decreases the distance between opposite sides ofthe mask seal between the compression ends. In one configuration, thescissor arms extend horizontally, across a front surface of the maskbase. In one configuration, the scissor arms extend vertically, across atop surface of the mask base.

In one configuration, the mask seal adjustment mechanism comprises twolugs attached to the mask seal and configured to receive straps from aheadgear assembly, the lugs extending beyond the outer surface of themask seal and configured to compress the mask seal and decrease thedistance between opposite sides of the mask seal between the lugs whentension is applied to the straps. In one configuration, the lugs aremolded as part of the mask seal.

In one configuration, the mask seal adjustment mechanism comprises twobuttons positioned within a channel defined by the mask base, and aratcheting lever arm, the buttons having first ends, second ends, andratcheting teeth configured to engage the ratcheting lever arm andretain the buttons in desired position, the second ends positioned atopposite sides of the mask seal, wherein pressing the first end of thebuttons moves the second ends of the buttons towards each other, anddecreases the distance between opposite sides of the mask seal betweenthe buttons.

In one configuration, the mask seal adjustment mechanism comprises adial; a first and second links coupled to the dial; and first and secondpaddles coupled to the first and second links; wherein the paddles arerotatably coupled to the mask base by first and second pins, and whereinturning the dial causes the links to push on proximal ends of the firstand second paddles, wherein pushing the proximal ends rotates thepaddles about the first and second pins and moves the paddles' distalends towards each other and squeezes the mask seal such that thedistance between opposite sides of the mask seal between the paddles'distal ends decreases as the dial is rotated.

A headgear assembly comprises a pair of upper straps and a pair of lowerstraps. One of the pair of upper straps and one of the pair of lowerstraps is connected to a first clip. Another of the pair of upper strapsand another of the pair of lower straps is connected to a second clip.The first clip and the second clip are securable within the pockets ofthe mask base such that the clips are brought into engagement within thepockets by moving in a direction substantially normal to a strap tensileforce direction.

In some configurations, the mask seal is a full face mask. In someconfigurations, the mask seal clip is integrated into the mask seal suchthat the mask seal clip is non-separable from the mask seal. In someconfigurations, the mask base is removably connected to the mask seal.In some configurations, the upper portion of the mask seal comprises anapex defined by a first wall and a second wall and the reinforcingcomponent extends along at least a portion of the first wall and alongat least a portion of the second wall. Preferably, the reinforcingcomponent extends over the apex of the upper portion of the mask seal.

A mask assembly can comprise a mask seal. The mask seal comprises anasal region and an oral region. The nasal region and the oral regionare integrally formed. The nasal region is movable relative to the oralregion such that forces exerted by the nasal region in multiplepositions remain substantially constant while forces exerted by the oralregion increase.

A mask assembly comprises a mask seal connected to a headgear assembly.The mask seal is configured to encircle a nasal bridge region and anoral region of a user. The mask seal comprises nonpleated means forapplying a substantially constant force to the nasal bridge region whileapplying increasing forces to an oral region when the headgear assemblyis tightened.

A mask assembly comprises a seal. The seal comprises a flange thatengages a face of a user. The seal is removably connected to a maskbase. The mask base comprises a first opening and a second opening. Thefirst opening and the second opening receive a first clip and a secondclip from an associated headgear assembly. The mask base furthercomprises a passageway positioned generally between the first openingand the second opening. The passageway is adapted to receive a breathingtube connector.

In some configurations, the mask assembly further comprises a mask sealclip that is connected to the mask seal and that is removably connectedto the mask base. Preferably, the mask base overlies a substantialportion of the mask seal clip. More preferably, the mask base comprisesa peripheral edge and at least one recess is defined along theperipheral edge of the mask base at a location that overlies the maskseal clip.

A mask assembly comprises a mask seal. The mask seal comprises aproximal flange adapted to contact a face of a user. The mask sealcomprises a distal facing surface. A mask base comprises a peripheraledge and a cover surface extends from the peripheral edge. The mask basecover surface overlies at least a portion of the distal facing surfaceof the mask seal such that the mask base cover surface is spaced apartin a distal direction from the mask seal distal facing surface wherebythe mask base cover surface and the mask seal distal facing surfaceprovide an insulating effect to the mask assembly that reduces humidityrainout.

An interface for providing positive pressure air flow to a user cancomprise a mask base and a mask seal removably connected to the maskbase. The mask seal comprises a first sealing surface that is adapted tounderlie a nose of a user and a second sealing surface that is adaptedto extend over at least a fibro-fatty tissue of one or more alar of thenose of the user without wrapping over a tip of the nose of the user.

In some configurations, the first sealing surface is defined by an uppersurface. A chamber can be defined within the seal member and an openingthrough the upper surface can be generally flush with the upper surface.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects and advantages of embodiments of thepresent invention will be described with reference to the followingdrawings.

FIG. 1 is front view of a user wearing an interface that is arranged andconfigured in accordance with certain features, aspects and advantagesof the present invention.

FIG. 2 is a side view of a user wearing the interface of FIG. 1.

FIGS. 3A-3D are views of an interface comprising a dial and cage sealadjustment mechanism.

FIGS. 4A-4H are views of an interface comprising a swing arm sealadjustment mechanism.

FIG. 5 is a front perspective view of an interface comprising a squeezebar seal adjustment mechanism.

FIGS. 6A-6E are views of an interface comprising a T-piece swing armseal adjustment mechanism.

FIGS. 7A-7B are views of an interface comprising a drum vice sealadjustment mechanism.

FIGS. 8A-8B are views of an interface comprising a cam and rocker sealadjustment mechanism.

FIGS. 9A-9E are views of an interface comprising a gear dial sealadjustment mechanism.

FIGS. 10A-10D are views of an interface comprising a taper dial sealadjustment mechanism.

FIGS. 11A-11G are views of an interface comprising a horizontal scissorseal adjustment mechanism.

FIGS. 12A-12H are views of an interface comprising a vertical scissorseal adjustment mechanism.

FIGS. 13A-13E are views of an interface comprising a lug assembly sealadjustment mechanism.

FIGS. 14A-14E are views of an interface comprising a ratcheting sealadjustment mechanism.

FIGS. 15A-15E are views of an interface comprising a dial and linkageseal adjustment mechanism.

FIGS. 16A-16C are views of an interface comprising a sliding sealadjustment mechanism.

FIGS. 17A-17E are views of an interface comprising a rotating sealadjustment mechanism.

FIGS. 18A-18D are view of an interface comprising a tabbed sealadjustment mechanism.

FIGS. 19A-19D are views of another interface comprising a tabbed sealadjustment mechanism.

FIGS. 20A-20B are views of an interface comprising a variable wallthickness adjustment mechanism.

FIG. 21 is a perspective view of a mask seal and mask seal clipcompatible with the interface of FIG. 1.

FIG. 22 is a perspective view of a mask seal and mask seal clip of theinterface of FIG. 1.

FIG. 23 is a rear perspective view of the mask seal clip of FIG. 22.

FIG. 24 is a rear elevation view of the mask seal clip of FIG. 22.

FIG. 25 is a side elevation view of the mask seal clip of FIG. 22.

FIG. 26 is a perspective view of the connection port assembly of FIG. 1.

FIG. 27 is a side elevation view of the connection port assembly of FIG.26.

FIG. 28 is a perspective view of the clip assembly of FIG. 1.

FIG. 29 is a cross sectional view of the clip assembly of FIG. 28 takenalong line 29-29.

FIG. 30 is a perspective view of a mask assembly comprising a mask,clips, and straps.

FIG. 31 is a side view of one of the two clips of FIG. 30.

FIG. 32 is an exploded view of the clip of FIG. 31.

FIG. 33 is a top view of the inner catch of the clip of FIG. 31.

FIG. 34 is a front view of a mask base having two mounting posts, andone inner catch of a clip mounted to the left mounting post.

FIG. 35 is a front view of another configuration of a mask base havingtwo mounting posts, and another configuration of a clip mounted to themask base's left mounting post.

FIGS. 36-45 are additional configurations of clips and associated masksand mounting posts.

FIGS. 46-46F are a perspective and various cross-sectional views of abackbone compatible with the headgear assembly of FIGS. 1 and 2.

FIG. 47 is an enlarged view of the end region of a lower arm of FIG. 46.

FIG. 48 is an enlarged cross-sectional view of the end region of FIG.47.

FIG. 49 is a side view photograph of the backbone of FIG. 46 attached toa user's head.

FIG. 50 is a rear perspective view photograph of the backbone of FIG. 46attached to a user's head.

FIG. 51 is a rear elevation view of the connection port assembly of FIG.27.

FIG. 52 is a sectioned side elevation view of the connection portassembly of FIG. 27.

FIG. 53 is a sectioned perspective view of the connection port assemblyof FIG. 22.

FIG. 54 is a side view of another configuration of a swivel assembly.

FIG. 55 is an exploded view of the swivel assembly of FIG. 54.

FIG. 56 is a cross-sectional view taken along line 56-56 of FIG. 53.

FIG. 57 is a cross-sectional view taken along line 57-57 of FIG. 53.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

With reference initially to FIGS. 1 and 2, an interface 100 is shown inposition on a user U. The interface 100 comprises an interface that canbe used in the field of respiratory therapy. The interface 100 hasparticular utility with forms of positive pressure respiratory therapy.For example, the interface 100 can be used for administering continuouspositive airway pressure (“CPAP”) treatments. In addition, the interface100 can be used with variable positive airway pressure (“VPAP”)treatments and bi-level positive airway pressure (“BiPAP”) treatments.The interface can be used with any suitable CPAP system.

The interface 100 can comprise any suitable mask configuration. Forexample, certain features, aspects and advantages of the presentinvention can find utility with nasal masks, full face masks, oronasalmasks or any other positive pressure mask. The illustrated mask is afull face mask. The interface 100 generally comprises a mask assembly102, a seal adjustment mechanism 103, a connection port assembly 104 anda headgear assembly 106. A mask seal 110 is attached to an edge of themask assembly 102, and generally traverses the mask assembly's 102perimeter. The headgear assembly 106 is used to secure the interface 100to the patient's face. As the headgear assembly 106 is tightened (e.g.,as its straps are pulled into tension), the interface 100 is pulled inan anterior direction F to compress the mask seal 110 against the user'sface. However, due to typical irregularity in the contours of a user'sface, the mask seal 110 may not adequately prevent air from escaping, orleaking, at all locations. In particular, the regions 105 of the maskseal 110 near the user's tear ducts can leak air. Air that escapes frominside the mask assembly 102 at the tear duct regions 105 can dry outthe user's eyes, and provide general discomfort during use. A sealadjustment mechanism 103 can provide additional control over mask seal110 compression and help eliminate air leakage, particularly around thetear duct regions 105.

The seal adjustment mechanism 103, shown in generic, block form in FIGS.1 and 2, provides a user-controllable, compressive force along an axistransverse to the mask assembly's 100 vertical plane of symmetry, whichis defined by the mask assembly's F and Z axes. In other words, the sealadjustment mechanism 103, provides a compressive force directed towardsthe side of the user's nasal bone, as indicated as directions C and C′in FIGS. 1 and 3. Any of a variety of mask configurations may beconfigured to comprise such seal adjustment mechanism 103, including,but not limited to, the particular mask configurations described below.In addition, any of a variety of seal adjustment mechanismconfigurations can help eliminate air leakage around the tear ductregion 105 without putting excessive forces on the user's nasal bridgeregion.

For example, FIGS. 3A-3D illustrates one such configuration of aninterface 700. The interface 700 comprises a mask assembly 702, a sealadjustment mechanism 704, a connection port assembly 706, and headgear(not shown). The mask assembly 702 comprises a mask seal 708 and a maskbase 710. The mask seal 708 is removably attached to the mask base 710.The seal adjustment mechanism 704 includes a dial 712, cage 714 andthreaded shaft 716. An interlock 718 couples the seal adjustmentmechanism 704 to the mask base 710.

As the control dial 712 is rotated, threads on the threaded shaft 716spin while engaged with an opening in the cage 714. Dial 712 rotationcauses the cage 714 to advance anteriorly A (towards the mask base 710)or posteriorly P (away from the mask base 710), depending upon whetherthe dial 712 is rotated in a clockwise or counterclockwise direction. Asthe cage 714 moves towards the mask base 710, arms 720 push against theoutside surface of the seal 708. Because the seal 708 is generally moreflexible than the mask base 710, this movement of the arms 720 causesthe flexible seal 708 to bend about the area where it is attached themore rigid mask base 710. As the seal 708 bends, the seal's distal ends724 are pushed inwardly, towards the user's nasal bone B. Thecompressive forces applied by the seal 708 help prevent air leakagearound the user's tear ducts.

Similarly, as the control dial 712 is rotated in the opposite direction,the cage 714 moves posteriorly, away from the user's face. As the cage714 moves posteriorly, the cage's arms 720 move away from the seal 708,which allows the seal 708 to flex back to its original shape. By turningthe control dial 712 the user may control the amount of compressiveforce provided by the seal adjustment mechanism 704 in order to achievemaximum comfort and to eliminate air leakage.

FIGS. 4A and 4B illustrate another configuration of an interface 730configured to provide a lateral compressive force to reduce air leakage.The interface 730 includes a mask assembly 732, a seal adjustmentmechanism 734, a connection port assembly 736, and headgear (not shown).The mask assembly 732 comprises a mask seal 738 and a mask base 740. Themask seal 738 is removably attached to the mask base 740. The sealadjustment mechanism 734 includes a lift bar 742 that is mounted to themask base 740 at pivots 744 located at opposite sides of the maskassembly 732.

As a crossbar portion 746 of the lift bar 742 is raised (e.g., moved inthe superior S direction towards the top of the interface 730), the ends748 of the lift bar 742 move in the opposite direction. Pads 750positioned at the lift bar 742 ends 748 compress or squeeze the seal 738as the ends 748 are lowered. In some configurations, the lift bar 742position is maintained as a result of frictional forces between the pads750 and the seal 738. In other configurations, a control mechanism 752is provided. For example, the configuration of FIGS. 4C-4E illustratethe interface 730 comprising a control mechanism 752 in the form of aratchet 754. A tongue 756 formed on the crossbar portion 746 of the liftbar 742 mates with teeth 758 formed on the outside surface of the maskbase 740. The ratchet 752 secures the crossbar portion 746 in thedesired position. Similarly, the configuration of FIGS. 4F-4H illustratethe interface 730 comprising a control mechanism 752 in the form of adial 760 and cog 762. The dial 760 is coupled to the cog 762 such thatas the dial 760 is rotated the cog 762 spins in the same direction.Teeth 764 in the cog 762 engage with teeth 766 located along a wall of acavity formed within the mask base 740. Turning the dial 760 therebyallows the user to control distance that the ends 748 of the lift bar742 are moved, which in turn control the amount of compressive force isapplied by the pads 750 against the mask seal 738. In this manner theuser may control the amount of compressive force provided by the sealadjustment mechanism 734 in order to achieve maximum comfort and toeliminate air leakage.

FIG. 5 illustrates another configuration of an interface 770 configuredto provide a lateral compressive force to reduce air leakage. Theinterface 770 includes a mask assembly 772, a seal adjustment mechanism774, a connection port assembly 776, and headgear (not shown). The maskassembly 772 comprises a mask seal 778 and a mask base 780. The maskseal 778 is removably attached to the mask base 780. The seal adjustmentmechanism 774 includes a malleable strip 782 that is attached to themask base 780 at attachment points 784.

The malleable strip 782 is formed from a malleable strip of materialthat can be easily shaped by sqeezing, pushing, or pulling on thematerial. The malleable strip 782 may be formed from any suitablematerial, such as metal, an alloy, or plastic, including but not limitedto, aluminum, copper, magnesium, gold, silver, tin, etc. The malleablestrip 782 extends from one side of the mask seal to the other. In otherconfigurations, the malleable strip 782 is embedded within the mask seal778. The malleable 782 extends within a channel formed in the mask base780. Pinching the malleable strip 782 at locations near or at theattachment points 784 causes the malleable strip 782 to apply andsustain a compressive force against the mask seal 778. In this mannerthe user may control the amount of compressive force provided by theseal adjustment mechanism 774 in order to achieve maximum comfort and toeliminate air leakage.

FIGS. 6A-6E illustrate another configuration of an interface 790configured to provide a lateral compressive force to reduce air leakage.The interface 790 includes a mask assembly 792, a seal adjustmentmechanism 794, a connection port assembly 796, and headgear 798(partially shown in FIG. 6B). The mask assembly 792 comprises a maskseal 800 and a mask base 802. The mask seal 800 is removably attached tothe mask base 802. The seal adjustment mechanism 794 includes a T-piece804 that is attached to the mask base 802 at pivots 806.

The T-piece 804 comprises tabs 808 that squeeze and compress the maskseal 800 as the T-piece 804 is rotated about the pivots 806 from an openposition (as shown in FIG. 6D) to a closed position (as shown in FIG.6E). Rotation of the T-piece 804 is achieved by tensioning the headgear798, as shown in FIG. 6B. The tabs 808 of the T-piece 804 are angledsufficiently inward with respect to the mask seal's 800 outer surfacesuch that tension in the headgear 798 is translated into mask seal 800compression. By adjusting the tension in the headgear's 798 straps, theuser may control the amount of compressive force provided by the sealadjustment mechanism 794 in order to achieve maximum comfort and toeliminate air leakage.

FIGS. 7A and 7B illustrate another configuration of an interface 810configured to provide a lateral compressive force to reduce air leakage.The interface 810 includes a mask assembly 812, a seal adjustmentmechanism 814, a connection port assembly (not shown), and headgear (notshown). The mask assembly 812 comprises a mask seal 816 and a mask base818. The mask seal 816 is removably attached to the mask base 818. Theconnection port assembly (not shown) attaches to the mask assembly 812at an opening 820 in the mask base 818.

The seal adjustment mechanism 814 comprises a finger wheel 822, a doublethreaded screw 824, and adjustment arms 826 positioned at opposite endsof the double threaded screw 824. As the finger wheel 822 is rotated,the screw 824 spins and causes adjustment arms 826 to move inwardly(towards each other) or outwardly (away from each other), depending uponthe direction of finger wheel 822 rotation. The adjustment arms 826 arepositioned outside of respective portions of the mask seal 816, suchthat the mask seal 816 is compressed as the adjustment arms 826 aremoved towards each other. Similarly, the compressive force acting uponthe mask seal 816 is reduced as the adjustment arms 826 are moved awayfrom each other. By rotating the finger wheel 822, the user may controlthe amount of compressive force provided by the seal adjustmentmechanism 814 in order to achieve maximum comfort and to eliminate airleakage.

FIGS. 8A and 8B illustrate another configuration of an interface 830configured to provide a lateral compressive force to reduce air leakage.The interface 830 comprises a mask assembly 832, a seal adjustmentmechanism 834, a connection port assembly 836, and headgear (not shown).The mask assembly 832 comprises a mask seal 838 and a mask base 840. Themask seal 838 is removably attached to the mask base 840.

The seal adjustment mechanism 834 comprises a dial 842 coupled to a cam844. The seal adjustment mechanism 834 also comprises L-shaped rockerarms 846 that are rotatably coupled to the mask assembly 832 at pivots848. First ends of the rocker arms 846 are aligned with the cam 844 andsecond ends of the rocker arms 846 are aligned with the mask seal 838.Rotating the dial 842 causes the cam 844 to rotate and engage ordisengage the first ends of the rocker arms 846 and push them upward andaway from the dial 842. As the first end of the rocker arms 846 moveaway from the dial 842, the second ends of the rocker arms 846 arerotated towards each other about respective pivots 848. The second endsof the rocker arms 846 engage and compress the outside surface of themask seal 838, thereby providing compressive force to improve sealing.By rotating the dial 842, the user may control the amount of compressiveforce provided by the seal adjustment mechanism 834 in order to achievemaximum comfort and to eliminate air leakage.

FIGS. 9A-9E illustrate another configuration of an interface 850configured to provide a lateral compressive force to reduce air leakage.The interface 850 comprises a mask assembly 852, a seal adjustmentmechanism 854, a connection port assembly (not shown), and headgear (notshown). The mask assembly 852 comprises a mask seal 858 and a mask base860. The mask seal 858 is removably attached to the mask base 860. Theconnection port assembly (not shown) attaches to the mask assembly 852at an opening 862 in the mask base 860.

The seal adjustment mechanism 854 comprises a gear dial assembly formedfrom a dial 864, a screw 866, and two geared paddles 868. Dial 864 isrotated to turn the threads on the screw 866. The rotating screw 866engages the geared ends of the paddles 868 and causes the paddles 868 torotate about respective pivots 870. Arms 872 attached to the paddles 868comprise compression portions 874 at their distal ends. The compressionportions 874 rotate into and compress the mask seal 858 as the dial 864is rotated. By rotating the dial 864, the user may control the amount ofcompressive force provided by the seal adjustment mechanism 854 in orderto achieve maximum comfort and to eliminate air leakage.

FIGS. 10A-10D illustrate another configuration of an interface 880configured to provide a lateral compressive force to reduce air leakage.The interface 880 comprises a mask assembly 882, a seal adjustmentmechanism 884, a connection port assembly (not shown), and headgear (notshown). The mask assembly 882 comprises a mask seal 888 and a mask base890. The mask seal 888 is removably attached to the mask base 890. Theconnection port assembly (not shown) attaches to the mask assembly 882at an opening 892 in the mask base 890.

The seal adjustment mechanism 884 comprises a taper dial assembly formedfrom a dial 894 and two arms 896. The dial 894 comprises a threadedouter surface 898 and a tapered internal channel 900. The dial 894 ispositioned within a thread 902 formed within or attached to the maskbase 890. As the dial 894 is rotated within the thread 902, the dial 894moves inward or outward with respect to the thread 902 and mask base890. When the dial 894 moves inward, proximal end portions 904 of thearms 896 interface with the tapered internal channel 900, which causesthe arms 896 to move towards each other. As the arms 896 move towardseach other, the arms' distal end portions 906 compress the outer surfaceof the mask seal 888. Similarly, rotating the dial 894 in the oppositedirection causes the dial 894 to move outward with respect to the maskbase 890. As the dial 894 move outward, proximal end portions 904 of thearms 896 move away from each other, thereby reducing the compression ofthe outer surface of the mask seal 888. By rotating the dial 894, theuser may control the amount of compressive force provided by the sealadjustment mechanism 884 in order to achieve maximum comfort and toeliminate air leakage.

FIGS. 11A-11G illustrate another configuration of an interface 910configured to provide a lateral compressive force to reduce air leakage.The interface 910 comprises a mask assembly 912, a seal adjustmentmechanism 914, a connection port assembly (not shown), and headgear (notshown). The mask assembly 912 comprises a mask seal 918 and a mask base920. The mask seal 918 is removably attached to the mask base 920. Theconnection port assembly (not shown) attaches to the mask assembly 912at an opening 922 in the mask base 920.

The seal adjustment mechanism 914 comprises a horizontal scissorsassembly formed from first and second scissor arms 924. The first andsecond scissor arms 924 connect to each other at a pivot 926 and extendfrom the rear toward the front of the mask assembly 912. The diameter ofthe pivot 926 is aligned with a vertical axis V that bisects the maskassembly 912. As first ends 928 of the scissor arms 924 are pinched andmoved towards each other, second ends 930 of the scissor arms 924 areadvanced towards each other, as well. The second ends 930 compriseenlarged regions configured to engage and compress the mask seal 918towards the vertical axis V. By pinching the first ends 928 of thescissor arms 924, the user may control the amount of compressive forceprovided by the seal adjustment mechanism 914 in order to achievemaximum comfort and to eliminate air leakage.

FIGS. 12A-12G illustrate another configuration of an interface 940configured to provide a lateral compressive force to reduce air leakage.The interface 940 comprises a mask assembly 942, a seal adjustmentmechanism 944, a connection port assembly (not shown), and headgear 946(partially shown). The mask assembly 942 comprises a mask seal 948 and amask base 950. The mask seal 948 is removably attached to the mask base950.

The seal adjustment mechanism 944 comprises a vertical scissor assemblyformed from first and second scissor arms 952. The first and secondscissor arms 952 connect to each other at a pivot 954 and extend from aposition above the top of the mask assembly 942 toward the bottom of themask assembly 942. The pivot 954 includes a geared interface in theconfigurations of FIGS. 12C-12E such that the rotation of one scissorarm 952 about the pivot 954 rotates the other scissor arm 952 about thepivot 954, as well. In the configuration of FIGS. 12F-12H, the pivot 954does not include a geared interface such that the scissor arms 952 areindependently movable with respect to the pivot 954.

Straps of the headgear assembly 946 attach to slots formed in at theupper ends of the scissor arms 952. As the straps are drawn intotension, the upper ends of the scissor arms 952 are pulled away fromeach other. Rotation of the upper ends of the scissor arms 952 away fromeach other causes the lower ends of the scissor arms 952 to rotatetowards each other. As the lower ends of the scissor arms 952 rotatetowards each other, they pinch and compress the mask seal (as shown inFIG. 12B). The lower ends of the scissor arms 952 are adhered to theoutside surface of the mask seal 948. In other configurations, the maskbase 950 extends in the upward direction, and the pivot 954 is attachedto the mask base 950. By tightening the straps of the headgear assembly946, the user may control the amount of compressive force provided bythe seal adjustment mechanism 944 in order to achieve maximum comfortand to eliminate air leakage.

FIGS. 13A-13E illustrate another configuration of an interface 960configured to provide a lateral compressive force to reduce air leakage.The interface 960 comprises a mask assembly 962, a seal adjustmentmechanism 964, a connection port assembly (not shown), and headgear 966(partially shown). The mask assembly 962 comprises a mask seal 968 and amask base 970. The mask seal 968 is removably attached to the mask base970. The connection port assembly (not shown) attaches to the maskassembly 962 at an opening 972 in the mask base 970.

The seal adjustment mechanism 964 comprises one or more lugs 974attached to or integrally formed with the mask seal 968. Straps of theheadgear assembly 966 pass through openings in the lugs 974 and attachto the mask base 970 at attachment points 976. In some configurations,the attachment points 976 are also lugs, as illustrated in FIGS.13A-13E. In other configurations, the attachment points 976 compriseclips, snaps, hook and loop fabric, etc.

As the headgear 966 straps are tensioned around the user's head, thelugs 974 are compressed into the mask seal 968, as shown in FIGS. 13Cand 13E. The mask seal 968 rotates about its connection to the mask base970 and compresses against the user's skin, typically along the side ofthe user's nose, in the direction of the side of the nasal bone. In thismanner, tensioning the straps in a first direction (posteriorly, towardsthe rear of the user's head) results in a transverse compressive force(laterally, inwardly, towards the center of the user's nose). Bytightening the straps of the headgear assembly 966, the user may controlthe amount of compressive force provided by the seal adjustmentmechanism 964 in order to achieve maximum comfort and to eliminate airleakage.

FIGS. 14A-14E illustrate another configuration of an interface 980configured to provide a lateral compressive force to reduce air leakage.The interface 980 comprises a mask assembly 982, a seal adjustmentmechanism 984, a connection port assembly (not shown), and headgearassembly (not shown). The mask assembly 982 comprises a mask seal 988and a mask base 990. The mask seal 988 is removably attached to the maskbase 990. The connection port assembly (not shown) attaches to the maskassembly 982 at an opening 992 in the mask base 990.

The seal adjustment mechanism 984 comprises a ratchet mechanism andbutton assembly configured to apply pressure on opposite sides of themask seal 988. The seal adjustment mechanism 984 comprises a button 994that slides within a channel of the mask assembly 982. As the userpresses against the outside surface of the button 994, the insidesurface of the button 994 presses into the side of the mask seal 988,thereby compressing the seal 988 laterally, for example, against theuser's nasal bone. A ratchet mechanism 996 (as shown in FIG. 14D)secures the button 994 in position, as the button's teeth 998 engage anend of a lever arm 1000. The lever arm 1000 attaches to the mask base990 at a pivot 1002, and rotates about the pivot 1002 to release thebutton's teeth 998 when pressed. A spring 1004 positioned within thebutton 994 biases the button 994 in an outward direction. The outwardbias provided by the spring 1004 allows the button 994 to pop out andrelease compressive forces applied to the mask seal 988 when the leverarm 1000 is pressed.

Another configuration of a ratchet mechanism 1006 is illustrated in FIG.14E. The ratchet mechanism 1006 also includes a button 1008 and alinkage assembly 1010. Pressing the button 1008 compresses the mask seal988 laterally, for example, against the user's nasal bone. Teeth in thebutton 1008 engage the distal end of the linkage assembly 1010 and holdthe button 1008 in position. Pressing the proximal end of the linkageassembly 1010 releases the teeth of the button 1008 from the linkageassembly's distal end. When released the button 1008 moves back to itsresting position, which releases the pressure applied by the button 1008against the mask seal 988. In some configurations, the ratchet mechanism1006 does not include a spring. Instead, the natural tendency of themask seal 988 to revert to its noncompressed state enables the button1008 to move outwardly to its open position when the proximal end of thelinkage assembly 1010 is pressed. By pressing on the buttons, the usercontrols the amount of compressive force provided by the seal adjustmentmechanism 984 in order to achieve maximum comfort and to eliminate airleakage.

FIGS. 15A-15E illustrate another configuration of an interface 1020configured to provide a lateral compressive force to reduce air leakage.The interface 1020 comprises a mask assembly 1022, a seal adjustmentmechanism 1024, a connection port assembly (not shown), and a headgearassembly (not shown). The mask assembly 1022 comprises a mask seal 1028and a mask base 1030. The mask seal 1028 is removably attached to themask base 1030.

The seal adjustment mechanism 1024 comprises a dial 1032, linkage 1034,and paddles 1036. The dial 1032 is secured to mask base 1030 via a pivot1035. Proximal ends of the linkage are attached to the dial 1032 atopenings within the dial 1032. The openings 1032 are larger than thediameters of the linkage proximal ends, such that linkage freely rotateswithin the openings as the dial is rotated about the pivot 1035.

The distal ends of the linkage 1034 fit within receptacles located atthe proximal ends of the paddles 1036. The paddles 1036 are secured tothe mask base 1030 at pivots 1038. The distal ends of the paddles 1036are comprise enlarged contact portions configured to compress the maskseal 1028.

As the dial 1032 is rotated, the linkage length changes from a shortconfiguration (as shown in FIGS. 15C and 15D) to a long configuration(as shown in FIGS. 15B and 15 E). In the short configuration, thelinkage arms pull the proximal ends of the paddles 1036 towards eachother and the dial 1032. As the proximal ends of the paddles 1036 arepulled towards each other and the dial 1032, the paddles 1036 rotateabout respective pivots 1038, such as pins 1038, and the distal ends ofthe paddles 1036 move apart and away from each other. Pressure appliedto the mask seal 1038 is released as the paddles 1036 move apart.

To compress the mask seal 1038, the dial 1032 is rotated to bring thelinkage length into the long configuration. In the long configuration,the linkage arms push the proximal ends of the paddles 1036 outward andaway from each other. The paddles 1036 rotate about their respectivepivots 1038 to bring their distal ends closer towards each other. Thepaddle 1036 distal ends compress the mask seal 1038 in a lateraldirection, for example, inward, toward the user's nasal bone. Byrotating the dial 1032, the user controls the amount of compressiveforce provided by the seal adjustment mechanism 1024 in order to achievemaximum comfort and to eliminate air leakage.

FIGS. 16A-16C illustrate one embodiment of a mask assembly 1600configured to provide a lateral compressive force against a user's nosein order to reduce air leakage. The mask assembly 1600 includes ahousing (sometimes referred to herein as a mask base) 1602 and a seal1604. The mask seal 1604 is removably attached to the mask base 1602.The mask assembly 1600 also includes a seal adjustment mechanism 1606.The mask assembly 1600 is compatible with any of the interfacesdescribed herein, and may be provided with a connection port assembly(not shown) and/or a headgear assembly (not shown).

The seal adjustment mechanism 1606 comprises a slider 1608, which in theillustrated embodiment, is formed as an end portion 1610 of the maskseal 1604. The slider 1608 may be integrally formed with the mask seal1604, or may be attached to the mask seal 1604. The slider 1608 and/orend portion 1610 may be made from a harder material than the mask seal1604. For example, in one embodiment, the slider 1608 is formed from aharder grade of silicone than the remaining portion of the mask seal1604.

The slider 1608 extends through a channel 1612 in the mask base 1602.Moving the slider 1608 within the channel 1612 adjusts the seal geometryaround the user's side nose bridge. For example, in one embodiment, theinclination angle 1614 between the seal side nose bridge portion 1616and the end plane 1618 of the seal 1604 increases or decreases dependingupon the distance and direction that the slider 1608 is moved. In oneembodiment, adjusting the slider 1608 from a first position, as shown inFIG. 16A to a second position, as shown in FIG. 16B, causes theinclination angle 1614 to adjust from about 35° (as shown in FIG. 16A)to about 50° (as shown in FIG. 16B). In other embodiments, theinclination angle 1614 is adjustable between about 20° and about 70°,between about 27° and about 60°, or between about 40° and about 45°. Asthe inclination angle 1614 is increased, the seal side nose bridgeportion 1616 applies less pressure against the side of the user's nose.As the inclination angle 1614 in decreased, the seal side nose bridgeportion 1616 applies greater pressure against the side of the user'snose. By adjusting the slider 1608, the user controls the amount ofcompressive force provided by the seal adjustment mechanism 1606 inorder to achieve maximum comfort and to eliminate air leakage.

The slider 1608 can include a control 1620 to facilitate manipulation bya user. The slider 1608 can also include a tang 1622 to help maintainthe slider 1608 in the desired position with respect to the base 1602once adjusted. The tang 1622 can be configured to contact an insidesurface of the base 1602. In one embodiment, frictional forces betweenthe tang 1622 and the base 1602 maintain the slider 1608 in the desiredposition. In other embodiments, the tang 1622 includes a ratchetingmechanism that interfaces with a corresponding structure on the maskbase 1602.

FIGS. 17A-17E illustrate one embodiment of another mask assembly 1700configured to provide a lateral compressive force against a user's nosein order to reduce air leakage. The mask assembly 1700 includes a maskbase 1702 and a mask seal 1704. The mask seal 1704 is removably attachedto the mask base 1702. The mask assembly 1700 also includes a sealadjustment mechanism 1706. The mask assembly 1700 is compatible with anyof the interfaces described herein, and may be provided with aconnection port assembly (not shown) and/or a headgear assembly (notshown).

The seal adjustment mechanism 1706 comprises a dial 1708, which in theillustrated embodiment, is positioned within an opening 1710 of the maskbase 1702. The dial 1708 is configured to rotate within the opening1710. The dial 1708 includes one or more channels 1712, through which anend portion 1714 of the seal 1704 extends. In the illustratedembodiment, the dial 1708 includes two channels 1712. An end portion1714 extends through each of the channels 1712. In some embodiments, theend portions 1714 are integrally formed with the seal 1704. In otherembodiments, the end portions 1714 are attached to the seal 1704. Forexample, in some embodiments, the end portions 1714 comprise one or morecables, wires, or other flexible member.

As the dial 1708 is rotated within the opening 1710, the end portions1714 wind (or unwind, depending upon the direction of rotation) aroundthe dial's outside surface 1716. As the end portions 1714 wind aroundthe dial's outside surface 1716, the seal 1704 is pulled upward, intension, towards the dial 1708, which causes an inclination angle 1718to increase. As the end portions 1714 are unwound from the dial'soutside surface 1716, the seal 1704 is relaxed, which causes theinclination angle 1718 to decrease.

In one embodiment, rotating the dial 1708 from a first position, asshown in FIG. 17C to a second position, as shown in FIG. 17D, causes theinclination angle 1714 to adjust from about 35° to about 50°. In otherembodiments, the inclination angle 1714 is adjustable between about 20°and about 70°, between about 27° and about 60°, or between about 40° andabout 45°. As the inclination angle 1714 is increased, the seal sidenose bridge portion 1720 applies less pressure against the side of theuser's nose. As the inclination angle 1714 in decreased, the seal sidenose bridge portion 1720 applies greater pressure against the side ofthe user's nose. By adjusting the dial 1708, the user controls theamount of compressive force provided by the seal adjustment mechanism1706 in order to achieve maximum comfort and to eliminate air leakage.

FIGS. 18A-18D illustrate another embodiment of a mask assembly 1800configured to provide a lateral compressive force against a user's nosein order to reduce air leakage. The mask assembly 1800 includes a maskbase 1802 and a seal 1804. The mask seal 1804 is removably attached tothe mask base 1802. The mask assembly 1800 also includes a sealadjustment mechanism 1806. The mask assembly 1800 is compatible with anyof the interfaces described herein, and may be provided with aconnection port assembly (not shown) and/or a headgear assembly (notshown).

The seal adjustment mechanism 1806 comprises a tab 1808, which in theillustrated embodiment, is formed as an end portion 1810 of the seal1804. The tab 1808 may be integrally formed with the mask seal 1804, ormay be attached to the mask seal 1804. The tab 1808 extends through anopening 1812 in the mask base 1802. The tab 1808 may include ratchetingfeatures or teeth that engage the edge of the mask base opening 1812.The teeth of the tab 1808 hold the end portion 1810 at the desiredposition.

Pulling or pushing the tab 1808 with respect to the base 1802 adjuststhe seal geometry around the user's side nose bridge. For example, theinclination angle 1814 between the seal side nose bridge portion 1816and the seal end plane 1818 increases or decreases depending upon thedirection that the tab 1808 is moved. For example, pulling the tab 1808from a first position (as shown in FIG. 18A) to a second position (asshown in FIG. 18B) adjusts the inclination angle 1814 from about 40° toabout 56°. In other embodiments, the inclination angle 1814 isadjustable between about 25° and about 70°, between about 35° and about60°, or between about 40° and about 50°. As the inclination angle 1814is increased, the seal side nose bridge portion 1816 applies lesspressure against the side of the user's nose. As the inclination angle1814 in decreased, the seal side nose bridge portion 1816 appliesgreater pressure against the side of the user's nose. By adjusting thetab 1808, the user controls the amount of compressive force provided bythe seal adjustment mechanism 1806 in order to achieve maximum comfortand to eliminate air leakage.

In some embodiments, a gasket 1820 is provided within the mask baseopening 1812. The gasket 1820 can provide a seal between the tab 1808and the mask base 1802. In one embodiment, the gasket 1820 is formed ofa flexible silicone material. The gasket 1820 is configured to flex froma first position when the tab 1808 is not pulled (as shown in FIG. 18C)to a second position when the tab 1808 is pulled (as shown in FIG. 18D).

In some embodiments, the mask assembly 1800 comprises a seal 1804 thatincludes at least one additional seal wall 1900. The additional sealwall 1900 is formed on an inside portion of the seal 1804. In someembodiments, the additional seal wall 1900 extends from the seal 1804 atthe location where the tab 1808 is formed. However, the additional sealwall 1900 may be provided with any of the mask seals described herein.In some embodiments, the seal wall 1900 extends from the seal 1804 nearor at the points where the seal 1804 intersects the seal end plane 1818,such as shown in FIGS. 19A and 19B. In other embodiments, the seal wall1900 extends from the seal 1800 near the points where the seal 1804 iscoupled to the mask base 1802, as shown in FIGS. 19C and 19D.

Pulling or pushing the tab 1808 with respect to the base 1802 adjuststhe seal geometry around the user's side nose bridge. For example, theinclination angle 1902 between the seal wall 1900 and the seal end plane1818 increases or decreases depending upon the direction that the tab1808 is moved. For example, pulling the tab 1808 from a first position(as shown in FIGS. 19A and 19C) to a second position (as shown in FIGS.19B and 19D) adjusts the inclination angle 1902 from about 40° to about56°. In other embodiments, the inclination angle 1902 is adjustablebetween about 25° and about 70°, between about 35° and about 60°, orbetween about 40° and about 50°. As the inclination angle 1902 isincreased, the seal wall 1900 applies less pressure against the side ofthe user's nose. As the inclination angle 1902 in decreased, the sealwall 1900 applies greater pressure against the side of the user's nose.By adjusting the tab 1808, the user controls the amount of compressiveforce provided by the seal adjustment mechanism 1806 in order to achievemaximum comfort and to eliminate air leakage.

FIGS. 20A and 20B illustrate illustrate one embodiment of a maskassembly 2000 configured to provide a lateral compressive force againsta user's nose in order to reduce air leakage. The mask assembly 2000includes a mask base 2002 and a seal 2004. The mask seal 2004 isremovably attached to the mask base 2002. The mask assembly 2000 alsoincludes a seal adjustment mechanism 2006. The mask assembly 2000 iscompatible with any of the interfaces described herein, and may beprovided with a connection port assembly (not shown) and/or a headgearassembly (not shown).

The seal adjustment mechanism 2006 is provided as a thinner section ofthe seal 2004 wall. In the illustrated embodiment, the thinner wallsection is formed between two notches 2008 in the wall of the seal 2004.The apexes of the notches 2008 are aligned with each other on oppositesides of the seal 2004. In some embodiments, the seal adjustmentmechanism 2006 includes 1, 3, 5 or less than 10 notches 2008. Thenotches 2008 may be provided on the outside and/or inside surface of theseal 2004. In some embodiments, the inside and outside notches arealigned with each other (as shown in FIGS. 20A and 20B), and in otherembodiments, they are not.

The outside notch 2008 is configured to open from about 45°, as shown inFIG. 20A, to about 90°, as shown in FIG. 20B. The seal 2004 bends at theadjustment mechanism 2006 as the mask assembly 2000 is applied to auser's face. When applied, the user's nose presses against the seal sidenose bridge portion 2010, which causes the seal side nose bridge portion2010 to bend with respect to the seal 2004 at the adjustment mechanism2006.

As the seal side nose bridge portion 2010 bends, the inclination angle2012 between the seal side nose bridge portion 2010 and the seal endplane 2014 changes. By adjusting the position of the mask assembly 2000on the user's face, the user controls the amount of compressive forceprovided by the seal 2004 in order to achieve maximum comfort andeliminate air leakage.

FIG. 21 illustrates one configuration of a mask assembly 102 compatiblewith any of the interface configurations described herein. The maskassembly 102 generally comprises a mask seal 110, which can include amask seal clip 112, and a mask base 114. As will be described, the maskseal clip 112 preferably connects the mask seal 110 to the mask base114. While the illustrated mask seal 110 and mask seal clip 112 areformed separately and secured together, in some configurations, the maskseal 110 and the mask seal clip 112 can be integrated into a singlecomponent. In some configurations, the mask seal 110 is overmolded ontothe mask seal clip 112. Indeed, in any of the mask assemblyconfigurations described above and below, the mask seal may be removablyattached to the mask base, or may be integrally formed with (e.g.,co-molded, permanently bonded, etc.) the mask base.

With reference to FIG. 22, the mask seal clip 112 is relatively morerigid, stiffer or more inflexible than the mask seal 110. In someconfigurations, the mask seal clip 112 is formed of a polycarbonatematerial. In some configurations, at least a portion of the mask sealclip 112 is formed of a polycarbonate or other rigid or semi-rigidmaterial. In some configurations, the mask seal clip 112 is formed atleast partially of silicone or another suitable material. In suchconfigurations, at least the silicone portion of the mask seal clip 112may be formed to be relatively thicker compared to the more flexibleportions of the mask seal 110. The mask seal clip 112 providesstructural support to the mask seal 110 in the illustratedconfiguration.

With reference to FIGS. 23 and 24, the illustrated mask seal clip 112comprises a substantially cup-shaped configuration. A proximal end 120defines an open end of the illustrated mask seal clip 112 while a distalend 122 defines a generally closed end of the illustrated mask seal clip112. In the illustrated configuration, the proximal end 120 is generallycircumscribed by a lip 124. The lip 124 is generally pentagonal whenviewed from the back. As shown in FIG. 25, a wall 126 generally sweepsforward in an arcuate manner. The arcuate shape to the wall 126 providesa three dimensional configuration to the illustrated mask seal clip 112.

With continued reference to FIG. 25, an upper portion 130 of theillustrated mask seal clip 112 is generally arcuate in configuration. Inaddition, the generally arcuate configuration of the illustrated maskseal clip 112 is configured to accommodate larger noses while notextending upward over the nose to as great an extent as the mask seal110, as shown in FIGS. 1 and 2.

Referring again to FIG. 22, the upper portion 130 of the illustratedmask seal clip 112 preferably comprises two arcuate dimensions. First,an arc length 132 can be defined along an upper extremity of the upperportion 130 of the illustrated mask seal clip 112. The arc length 132can be defined between inflection points 134 found along a perimeter ofthe illustrated mask seal clip 112.

As shown in FIG. 25, the upper portion 130 of the illustrated mask sealclip 112 also comprises a side profile radius 136. As shown, the upperportion 130 can have a slightly increasing side profile radius 136 suchthat the radius increases slightly as a distance from the upper endincreases. In some configurations, the upper portion 130 can comprise asubstantially constant side profile radius 136 or a decreasing sideprofile radius. Advantageously, the slightly increasing side profileradius 136 provides an increased volume in the mask 100 proximate theuser's nose.

With reference to FIG. 22 and FIG. 24, the mask seal clip 112 preferablycomprises at least two recesses 140. In the illustrated configuration,the mask seal clip 112 comprises two recesses 140 that are disposed ontwo lateral sides of a generally vertical center plane CP (see FIG. 24).The generally vertical center plane CP preferably corresponds to amid-sagittal plane of the user and splits the illustrated mask seal clip112 into substantially mirror image halves. The two recesses 140 definetwo generally enclosed pockets in the illustrated mask seal clip 112.The illustrated recesses 140 comprise further recesses 142 that are usedto provide adequate clearance for reasons that will be discussed belowwhile limiting an amount of encroachment into a nasal region of achamber defined by the mask assembly 102.

The illustrated mask seal also comprises a generally central passage 144that is defined by a wall 146. In the illustrated configuration, thewall 146 generally encloses the passage 144. Preferably, the wall 146 isgenerally cylindrical in configuration and extends through the wall 126.Other configurations are possible.

With reference now to FIGS. 1 and 2, the mask assembly 102 includes themask base 114, which is more rigid than the mask seal 110. The mask base114 can be formed of any suitable material. In some configurations, themask base 114 is formed of a polycarbonate material such that it iscapable of flexing for connection with the mask seal 110 and/or the maskseal clip 112.

With reference now to FIG. 21, the mask assembly 102 is shown with themask base 114 secured to the mask seal 110. More particularly, in theillustrated configuration, the mask base 114 is secured to the mask sealclip 112 that is attached to the mask seal 110 in any suitable manner.In some configurations, the mask base 114 and the mask seal 110 or maskseal clip 112 are removably connected. In some configurations, the maskbase 114 snaps together with one or both of the mask seal 110 and themask seal clip 112. Preferably, the mask seal 110 and the mask seal clip112 can be removed from the mask base 114 and a snap connection securesthe mask seal clip 112 to the mask base 114.

The illustrated mask base 114 overlies at least a portion of the maskseal clip 112. In some configurations, the mask base 114 almost entirelycovers the mask seal clip 112. In some configurations, the mask base 114extends over more than half of the mask seal clip 112. When the maskbase 114 overlies a substantial portion of the mask seal clip 112 or themask seal 110, a double layer effect is created (e.g., the mask sealclip 112 and the mask base 114). The double layer effect providesincreased insulation when a significant portion of the mask base 114overlaps a significant portion of the mask seal clip 112 or the maskseal 110. The increased insulation provides a warmer inner portion(e.g., mask seal 110 and/or mask seal clip 112), which results in lessrain out of humidity during use. Preferably, at least a portion of themask seal clip 112 is exposed from under the mask base 114 such that themask base 114 can be more easily separated from the mask seal clip 112.To aid in the separation of the mask base 114 from the underlying maskseal 110 and/or mask seal clip 112, the illustrated mask base 114comprises a peripheral surface 200 on the proximal end. The mask base114 is concave on the inside to accommodate the underlying components.In other words, the mask base 114 is bowl shaped in a distal directionrelative to the proximal peripheral surface 200.

The peripheral surface 200 comprises one or more recessed portions 202.Preferably, the recessed portions 202 comprise at least two recessedportions 202 that are positioned on opposite sides of the mask base 114from each other. The recessed portions 202 are configured to receive athumb and a finger such that the mask base 114 can be more easilyremoved from the front of the underlying mask seal clip 112. While therecessed portions 202 can define means for grasping the assemblyunderlying the mask base 114 for removal of the mask base, otherconfigurations can be used, such as outwardly extending tabs, protrudingportions and the like, for example but without limitation. In addition,while the illustrated recessed portions 202 are disposed on opposinglateral sides of the mask base 114, the recessed portions 202 can bepositioned on the top and bottom or on other regions as desired.

As shown in FIG. 21, the mask base 114 preferably comprises an opening210 that is defined by a wall 212. The wall 212 that defines the opening210 through the mask base 114 preferably fits within the wall 146 thatdefines the passage 144 through the mask seal clip 112. The wall 212 canbe axially coextensive with the wall 146. In addition, the dimensionsand shapes of the walls 146, 212 can be such that the walls interactwith each other to reduce relative slippage between the walls 146, 212and to reduce the likelihood of the mask seal base 114 inadvertentlyseparating from the mask seal clip 112. In some configurations, thewalls 146, 212 fit together and reduce the likelihood of leakage throughthe interface between the walls. Preferably, a taper lock secures thewalls 146, 212 together.

The wall 212 comprises a contoured inner surface 214. The contouredsurface 214 can be radiused to receive a ball end 220 of a swivelingelbow 222, such as that shown in FIG. 26. As better shown in FIG. 27,the ball end 220 has a contoured surface 224 that can be snap fit intothe contoured surface 214 formed in the mask base 114. The connectionbetween the two contoured surfaces 214, 224 allows the surfaces to sliderelatively freely with each other such that the position of theswiveling elbow 222 can be easily changed. In some configurations, theelbow 222 could be configured for rotation or swiveling without having aball-joint configuration.

With reference again to FIG. 21, the mask base 114 also comprises atleast two pockets 230. The illustrated mask base 114 comprises twopockets 230. The pockets 230 recede into the mask base 114 and protruderearward from the mask base 114. The pockets 230 are received within therecesses 140 of the mask seal clip 112. Overlying the further recesses142 formed in the mask seal clip 112 are openings 232 that are definedby a surrounding wall 234.

The illustrated pockets 230 are formed such that one pocket 230 isformed on each lateral side of the mask base 114. The pockets 230 can bepositioned to be symmetrical relative to the central plane CP, whichplane substantially bisects the mask base 114. In some configurations,the pockets 230 have an enlarged vertical dimension 240 relative to atransverse dimension 242. Similarly, the openings 232 have an enlargedvertical dimension 244 relative to a transverse dimension 246.

In the illustrated mask base 114, the laterally inward portion of eachpocket 230 comprises a support wall 250. The support wall 250 ispositioned toward the center plane CP relative to normal to a basesurface 248 of the pocket 230. Each of the pockets 230 is configured toreceive a clip 252 (see FIG. 28). Once the clip 252 is installed withinthe pocket 230, the support wall 250 helps to limit rotation of the clip252 relative to the pocket 230. Moreover, the large vertical dimensionhelps users to locate the pocket 230 with the clip 252 duringinstallation.

With reference to FIG. 28, the clip 252 can have a two partconstruction: an outer cover 254 and an inner catch 256. Straps 260 canbe secured to each clip 252 in any suitable manner. One suitableconfiguration is illustrated in FIG. 2. In some configurations, thestraps 260 can be sandwiched between the outer cover 254 and the innercatch 256. In some configurations, loops or openings or holes could beprovided on the clips 252 through which the straps 260 are threaded.Preferably, one clip 252 can be connected to both an upper strap and alower strap of the headgear assembly 106. Such a configurationfacilitates easy connection of the headgear assembly 106 to the fullface mask assembly 102 and easy disconnection of the headgear assembly106 from the full face mask assembly 102.

As shown in FIG. 29, the clip 252 comprises a sloping surface 262. Thesloping surface 262 can be positioned on the outer cover 254. Thesloping surface 262 cooperates with the support wall 250 to help orientthe clip 252 relative to the pocket 203 of the mask base 114.

The clip 252 includes an interlock feature 264. The interlock feature264 is configured for insertion into the opening 232 defined in thepocket 230 of the mask base 114. The interlock feature 264 can engage ina snap-fit manner with a tab 236 defined along the wall 234 that definesthe opening 232 in the mask base 114, as shown in FIG. 21. Other mannersof interlocking the clip 252 with the pocket 230 also can be used.

Referring to FIG. 29, the interlock feature 264 of the illustrated clip252 comprises a U-shaped component 268 that terminates in a releaselever 266. The U-shaped end 268 protrudes a sufficient distance to allowthe connection with the tab 236 but does not protrude so far as to allowthe bottom of the further recess 142 in the mask seal clip 112 to stopproper insertion of the interlock feature 264 into the opening 232. TheU-shaped end 268 initially makes contact with a wall of the opening 232during connection of the clip 252 to the mask base 114. In theillustrated configuration, the U-shaped end 268 contacts the wall 234 ofthe opening 232 during insertion and the wall 234 guides the clip 252into position within the pocket 230. The opening 232, or one or moresurfaces that define the opening 232, generally align the clip 252relative to the mask base 114 during connection of the clip 252 to themask base 114.

The end of the release lever 266 protrudes through an opening 270defined by a wall 272. Preferably, the end of the release lever 266protrudes through the opening 270 a sufficient distance to allow easymanipulation of the release lever 266. Moving the release lever 266 inmanner that closes the U-shape of the interlock feature 264 allows theinterlock feature 264 to be removed from engagement with the tab 236 inthe wall 234 that defines the opening 232 in the mask base 112.

FIGS. 30-37 illustrate additional configurations of clip assemblies 252that are configured to secure a mask assembly 102 to a user's head. Theclip 252 of FIGS. 30 and 31, for example has a raised edge 400(sometimes referred to as a finger tab 400) that enables the user toeasily detach the headgear 106 from the mask assembly 102. The raisededges 400 are oriented such that the user may merely pull themrearwardly to pop the clips 252 off of the mask base 114. Removing oneor more clips 252 from the mask base 114 allows the mask assembly 102 tobe easily removed from the user's head. The raised edge 400 provides agrasping point during attachment and removal of the headgear 106 withrespect to the mask assembly 102. For example, the user's thumb andindex finger may be placed on opposite sides of the raised edge 400during removal of the clip 252 from the mask assembly 102. In addition,the user may grip the clip 252 and maintain the grip throughout the maskfitting process. This eliminates the need to grasp blindly for straps260 during assembly. It also allows the user to attach the clip 252,remove it, and re-attach it while maintaining a grip on the raised edge400.

FIG. 32 shows an exploded view of the clip 252 of FIGS. 30 and 31.

The clip 252 includes an outer cover 254 and an inner catch 256. Theinner catch 256 includes one or more slots 402 to receive the distal endof the headgear straps 260. The inner catch 256 can also include severalpressure bumps, such as those shown in connection with the configurationof FIGS. 36 and 37. The pressure bumps provide additional pressureagainst the outer cover 254 and inner catch 256, so that they aresecured to one another. In one configuration, the headgear straps 260are removable from the assembled clip 252.

The inner catch 256 includes an elongated slot 404, as shown in FIG. 36.The slot 404 includes a circular opening 406 having a diameter largerthan the width of the slot 404. The slot 404 and circular opening 406can include chamfered recesses to help align the clip 252 to the maskassembly 102. The circular opening 406 facilitates attachment andremoval of the clip 252 to the mask assembly 102, as will be discussedin greater detail below. Two channels 408 extend parallel to the sidesof the slot 404, thereby defining slot walls 410 (sometimes referred toas clip levers) on either side of the slot 404. The channels 408 aresized to permit adequate flexing of the slot walls 410 during attachmentand removal of the clip 252 from the mask assembly 102. In addition, theslot walls 410 extend along the longest dimension of the inner catch256, towards top and bottom, which allows longer slot walls 410 to beemployed. Longer slot walls 410 reduces the level of stress on the slotwalls when fitting the clip over the mounting post.

One configuration of a mask base 114 suitable for use with the clip 252of FIGS. 30-33 is illustrated in FIG. 34. The mask base 114 includes tworecesses 140 symmetrically positioned on opposite sides of the mask base114. A mounting post 412 extends from the body of the mask base 114within each recess 140. The mounting post 412 may be integrally formedwith the mask base 114, or separately formed and secured to the maskbase 114. The mounting post 412 can have a mushroom-shaped configurationto secure the clip 256 to the mask base 114 once the user snaps the clip256 in place. The rounded top of the bulbous mushrooms-shaped post 412helps locate and orient the central hole 406. As the clip 252 is pressedonto the post 412, the slot walls 410 deflect outwardly, away from thepost 412. Once the head of the post 412 clears the edge of the slot wall410, the slot walls 410 snap back to their original position, therebyproviding tactile, and sometimes audible feedback, that the clip 252 isproperly attached to the mask assembly 102.

The mounting post 412 can also comprise an elongated, elliptical,elevated portion 414 (sometimes referred to as a lug or wing) that issized to mate with the elongated slot 404 of the inner catch 256. Theelongated, elevated portion 414 comprises a chamfered edge to helpproperly align the head gear 106 with respect to the mask assembly 102.The portion 414 also prevents the clip 252 from rotating with respect tothe mask assembly 102. This helps assure constant tension on theheadgear straps 260 while the user sleeps.

FIG. 42 illustrates a partial assembly of yet another configuration tosecure a clip 252 to a mask base 114 of a mask assembly. The clip 252sits within a recess 140 of the mask base 114. A cylindrical,button-head post 412 extends from the surface of the mask base 114within the recess 140. The post 412 allows slight rotation of the clip252 when attached thereto due to its cylindrical configuration. However,as shown in FIG. 36 and FIG. 37, the slot 404, channels 408 and slotwalls 410 extend along the shorter planar direction of the inner catch256, towards its front and back ends.

The inner catch 256 also includes several pressure bumps 414. Asdiscussed above, the pressure bumps provide additional pressure againstthe outer cover 254 and inner catch 256, so that they are secured to oneanother.

Additional configurations of a clip 252 are illustrated in FIGS. 38-45.The clip 252 of FIG. 38 includes three elongated, elliptical slots 404and a finger tab 400. The finger tab 400 is used to create a lever torelease the clip 252 from a mask assembly 102. The central slot 404 issized to receive a mounting post 412 that extends from the outsidesurface of the mask body. One such suitable mounting post 412 isillustrated in FIG. 41. The mounting post 412 includes a ridge 414 andtwo slots 416. As the clip 252 is pressed onto the mounting post 412,the outer portions of the post 412 flex towards each other due to thespacing provided by the slots 416. Once the ridge 414 clears the uppersurface of the clip 252, the mounting post 412 snaps back to itsoriginal position, and the ridge 414 locks the clip 252 in place,

A similar configuration is shown in FIGS. 42-45. The clip 252 of FIG. 43does not include a finger tab and its central opening 404 has a rounder,more elliptical shape than the elongated slots of FIGS. 38-41.

All of the foregoing configurations simplify the procedure for securingthe mask assembly 102 to the user's head. For example, the clips 252allow the headgear 106 to open up so that it is not a closed loop. Byopening up, the headgear 106 may be swung around the head rather thanforcing the user to pull his head through it.

With reference to FIG. 2, in addition to the straps 260, the headgearassembly 106 also comprises a back strap 280 and a top strap 282. Otherhead gear assemblies also can be used. The back strap 280 extends aroundthe back of the head of the user U at a location generally above a napeof the neck but generally below the occipital protuberance. At alocation rearward of the ear of the user, the back strap 280 forks intoan upper arm 284 and a lower arm 286. The upper arm 284 arcs upward to alocation above the ear of the user and then arcs downward to a locationgenerally forward of the ear of the user. The lower arm 286 arcsdownward to a location generally below the ear of the user and extendsslightly forward of the ear.

The straps 260 can be connected to the back strap 280 in any suitablemanner. In the illustrated configuration, the straps 260 connect to theupper arm 284 and the lower arm 286 respectively. Preferably, the upperarm 284 and the lower arm 286 are more rigid than the straps 260 suchthat the arms 284, 286 generally maintain shape as the headgear assembly106 is being donned. In some configurations, each of the upper arm 284and the lower arm 286 supports its own weight. In some configurations,each of the upper arm 284 and the lower arm 286 is structured to betangle-free during donning. For example, the arms 284, 286 havesufficient torsion stiffness to reduce the likelihood of twisting whenbeing put on.

Preferably, the straps 260 connect to at least one of the upper arm 284and the lower arm 286 at a location forward of the ear. Such aconfiguration helps the user to locate the straps 260 without muchdifficulty. In addition, because the straps 260 in the illustratedconfiguration are embedded into the clips 252, the ends of the upperarms 284 and the lower arms 286 can comprise slots 290, 292 such thatthe straps 260 can be threaded through the slots 290, 292. In addition,the straps 260 can comprise an adjustment mechanism 294, such as aVelcro or buckle configuration. The adjustment mechanism 294 allows aforce between the mask seal 110 and the face of the user U to beadjusted. Any suitable adjustment mechanism 294 can be used.

As shown in FIG. 2, the top strap 282 preferably is flexible and has anadjustable length. The top strap 282 connects to the upper arms 284through a slot 296 and reduces the likelihood of the upper arms 284sliding down the head of the user and contacting the ears of the user.Preferably, the top strap 282 connects to the upper arms 284 at alocation generally above the ears of the user.

Advantageously, as shown in FIGS. 1 and 2, the straps 260 exert a forcein the direction of the arrow F while they connect to the mask base 114by movement in the direction C, which direction is generally normal tothe direction of the force F. In other words, the straps 360 aretensioned by pulling forward and the clips 252 are connected to the maskbase 114 by movement in a direction normal to the forward pull. Such aconfiguration eases securement of the interface 100 on the face of theuser.

In another configuration, the headgear assembly 106 includes asemi-rigid headgear 380 (as shown in FIG. 41) to secure the maskassembly 102 to the user's head. The semi-rigid headgear 380 is formedas a composite structure comprising a semi-rigid strap 382 that isjoined to a soft edging 384. For example, the soft edging 384 can bebonded to the semi-rigid strap 382 by plastic overmolding or by use ofan adhesive. As shown in FIG. 46, the soft edging 384 can be butt-joinedto the semi-rigid strap 382, without the soft edging 384 overlapping thesemi-rigid strap 382, to maintain the continuous profile of thesemi-rigid headgear 380. The semi-rigid strap 382 defines and maintainsthe semi-rigid headgear shape as tension is applied from the straps 260to pull the mask assembly 102 towards the user's head. In other words,the semi-rigid strap 382 is sufficiently rigid along its planar axis toprevent its upper and lower arms 284, 286 from overly deforming undertension. The semi-rigid strap 382 can be made from a variety of rigid orsemi-rigid materials, including plastic or metal. In someconfigurations, the semi-rigid strap 382 is made from PVC.

Especially in connection with a semi-rigid headgear assembly, it hasbeen found that the shape holding, or self-supporting nature, can resultin an overall assembly that is intuitive to fit. In particular, wherethe connection and/or headgear members are self-supporting such thatthey maintain a three-dimensional form, the headgear can be fitted inthe correct orientation with very little if any instruction. In aself-supporting arrangement, the tendency of the straps to not tanglealso reduces the time taken to fit the overall assembly.

As used herein, the term “semi-rigid” is used to denote that theheadgear assembly is sufficiently stiff such that the headgear assembly380 can assume a three-dimensional shape with dimensions approximatingthe head of the patient for which the headgear is designed to fit whilealso being sufficiently flexible to generally conform to the anatomy ofthe patient. For example, some of the other components (e.g., arms orstraps) of the headgear assembly 380 may also be partially or wholly“semi-rigid” such that the components are capable of holding athree-dimensional form that is substantially self-supporting. A“semi-rigid” headgear assembly is not intended to mean that each andevery component of the headgear assembly is necessarily semi-rigid. Forexample, the substantially three-dimensional form that theself-supporting headgear assembly 380 may assume may relate primarily tothe rear and top portions of the headgear assembly 380. In addition, thesemi-rigid headgear assembly 380 may include semi-rigid regions thatextend forward of the ears and above the ears when placed on the head ofthe patient.

The left and right upper and lower arms 284, 286 may be formed of asemi-rigid material, as well. Where used herein, the semi-rigidmaterials may include molded plastic or sheet materials that include butare not limited to homogeneous plastic materials and bonded non-wovenfiber materials.

In some configurations, one or more of arms or straps are formed of asubstantially inelastic material. The arms or straps can be formed of asemi-rigid, self-supporting material such that the semi-rigid headgearassembly 380 can assume a substantially three-dimensional shape andgenerally does not tangle. In some configurations, the material cancomprise a laminate structure of both conformable and semi-rigidportions, for example but without limitation. The semi-rigid strap 382may be of a self-supporting, resilient, substantially inelasticmaterial, such as Santoprene, polyolefin, polypropylene, polyethylene,foamed polyolefin, nylon or non-woven polymer material for example butwithout limitation. In some configurations, the semi-rigid strap 382 isformed from the polyethylene or polypropylene families. The material canbe a low density polyethylene such as Dowlex 2517, which is a linear lowdensity polyethylene that has a yield tensile strength of 9.65 MPa, abreak tensile strength of 8.96 MPa, and a flexural modulus—2% secant of234 MPa. The semi-rigid strap 382 preferably is formed of a materialsuch that the semi-rigid headgear 380 is substantially shape-sustainingunder its own weight regardless of its orientation. In someconfigurations, the semi-rigid strap 382 does not stretch more thanapproximately 6 mm under a 30 N tensile load. In some configurations,the semi-rigid strap 382 does not stretch more than approximately 3 mmunder a 30 N tensile load.

In some configurations, the semi-rigid strap 382 is formed from nonwoven polyolefin (NWP), which is bonded (e.g., overmolded or laminated)with a polyolefin. In such configurations, the overmolded polyolefinmaterial provides the principle shape sustaining properties. Inaddition, the softer NWP material is adapted to contact the skin andprovide a desired comfort level. Furthermore, the NWP material mayassist in providing the desired load bearing properties, such as thedesired tensile load bearing properties.

The semi-rigid headgear 380 is generally formed of a semi-rigidmaterial. Where used herein, the semi-rigid materials may include moldedplastic or sheet materials that include but are not limited tohomogeneous plastic materials and bonded non-woven fiber materials. Theupper and lower arms 284, 286 also include such semi-rigid materials, asthe arms 284, 286 are formed integrally with and are portions of thesemi-rigid headgear 380. Preferably, the right and left lower arms 286are formed as an integrated component that, in use, will extend aroundthe back of the head and above the neck of the patient.

A soft edging 384 covers or attaches to at least a portion of theperiphery of the semi-rigid strap 382. In one configuration, the softedging 384 does not cover the front or rear faces of the semi-rigidstrap 382. For example, the thicknesses of the soft edging 384 andsemi-rigid strap 382 can be the same at the location where they arejoined together.

The soft edging 384 provides a soft, comfortable interface between theperiphery of the semi-rigid strap 382 and the user's skin. The softedging 384 can be made from a variety of soft materials, including butnot limited to a plastic, an elastomer, silicone or thermoplasticpolyurethane (TPU) plastic. The soft edging 384 can have a Shorehardness in the range of 10-80 Shore A.

As used herein with respect to headgear and straps, “soft” is used todescribe a hand of the material, which means the quality of the materialassessed by the reaction obtained from the sense touch. In addition, asused herein with respect to headgear and straps, “conformable” is usedto describe the ability of the material to conform to the anatomicalfeatures of the patient (e.g., around a facial feature). In particular,a strap including at least an element of “soft” and/or “conformable”material also may be “semi-rigid” and/or axially inelastic.

The soft edging 384 can have a uniform thickness, or in someconfigurations, an uneven thickness. For example, in some configurationsthe soft edging 384 is the same thickness as the semi-rigid strap 382.In other configurations, the soft edging 384 is thinner than thesemi-rigid strap 382, forms a bulbous end to the semi-rigid strap 382,or is simply thicker than the semi-rigid strap 382. A variety ofcross-sectional views of the semi-rigid headgear 380 are shown in FIG.46. Each cross-sectional view (A-A′ through F-F′) shows one possibleconfiguration of semi-rigid strap 382 and soft edging 384 thicknesses,which may be combined as desired. For example, any one particular softedging 384 thickness and shape could apply to a portion or the entiresemi-rigid strap 382, or may be combined with any other particularcovering thickness and shape shown in FIG. 46.

Many other thickness configurations may be provided, as well. Inaddition, material thickness may be symmetrically or asymmetricallyapplied to the semi-rigid strap 382. For example, cross-sectional viewsC-C′ and F-F′ are shown as asymmetric; however, in other configurationsthe thickness of either end the soft edging 384 is symmetrically appliedto the semi-rigid strap 382. In some configurations the semi-rigid strap382 is selectively thickened to provide extra rigidity and support. Forexample, the second of the two configurations illustrated ascross-sectional view F-F′ has such a thickening. Finally, in someconfigurations, venting through-holes 396 are provided throughout thesemi-rigid headgear 380 (such as on the semi-rigid strap 382, as shownin FIG. 46, or on soft edging 384) to provide ventilation and sweatmanagement.

When laid flat, as shown in FIG. 46, the semi-rigid headgear 380 definesthree C-shaped, arcuate regions 386, 388, 390. Two ear-surroundingregions 386, 388 are defined by upper and lower arms 284, 286, and arear region 390 is defined by lower arms 286 and the back strap portion280. The semi-rigid headgear 380 is flexible enough to bend to adapt tothe shape of the user's head, such that the ear-surrounding regions 386,388 at least partially surround or encircle the user's ears, and therear region 390 at least partially surrounds or encircles the back ofthe user's head, above the neck.

The curvature of each arm 280, 284, 286 can be selected to provide acomfortable fit and to facilitate application and removal of thesemi-rigid headgear 380 from the user's head. For example, in theillustrated configuration, the upper arms 284 have a concave curvatureand the lower arms 286 have a convex curvature with respect to theopening in the upper ear surrounding arcuate regions 386, 388. The backstrap portion 280 and the lower arms 286 all have a concave curvaturewith respect to opening in the neck surrounding arcuate region 390.These curvatures facilitate application and removal of the semi-rigidheadgear 380 from the user's head by, for example, providing openings tothe arcuate regions sized and oriented to easily fit over a user's neckand ears.

The configuration of FIG. 46 utilizes integrated crown straps comprisingfirst and second crown arms 392, 394 to secure the semi-rigid headgear380 to the user's head. Once the semi-rigid headgear 380 is positionedto partially surround the user's head, the first and second crown arms392, 394 are brought into contact with one another to secure thesemi-rigid headgear 380 in place. Any of a variety of mechanisms can beprovided with the first and second crown arms 392, 394 to enable them toattach to one another. For example, in some configurations, ahook-and-loop fabric (e.g., Velcro), or one or more snaps or clips canbe used to attach the first and second crown arms 392, 394 to oneanother.

The crown straps extend laterally over the top of the skull in line withthe ears. When the crown straps extend in this manner and the arcuateregions 386, 388 are positioned to partially encircle the user's ears,the back strap 280 of the semi-rigid headgear 380 should locate on orbelow the inion. The user's inion is the most prominent projection ofthe occiptal bone at the posterioinferior portion of the skull. In otherwords, the inion is the highest point of the external occipitalprotruberance. The semi-rigid headgear 380 can be positioned on theuser's head according to any desired configuration.

For example, the back strap portion 280 is adapted to engage with therear of head of the user. Preferably, the back strap portion 280 isadapted to engage with the head at a location on or below the externaloccipital protuberance. The back strap portion 280 spans the distancearound the back of the head and extends to each side of the head. Insome configurations, the back strap portion 280 comprises a longitudinalcenter that is adapted to be located about 25 degrees below a horizontalplane that extends through the ear canal of the patient.

On either side of the head, the semi-rigid headgear 380 extends upwardand downward into left and right side regions that form arcuate regions386, 388. The side regions are adapted to extend behind the ears of thepatient. Preferably, the side regions also are adapted to extend behindthe mastoid processes of the patient. Each of the left and right sideregions of the semi-rigid headgear 380 extends into or comprises anarched portion 386, 388. The arched portions 386, 388 bend forward. Thearched portions 386, 388 are adapted to extend around the respectiveears of the patient. Preferably, each of the arched portions 386, 388terminates at a respective termination portion. The termination portionspreferably are adapted to be located forward of the ears of the patient.In some configurations, the side regions and the arched portions 386,388 of the semi-rigid headgear 380 do not include a soft inner paddingportion but may comprise a self-supporting, resilient material that isin direct contact with the head/hair of the patient.

The top portion of the semi-rigid headgear 380 connects the archedportions 386, 388 together. The top portion can be positioned forward ofthe ears in some configurations. Preferably, the top portion ispositioned generally vertical from the ears. More preferably, alongitudinal center of the top portion is adapted to be spaced more than13 mm, preferably between 13-100 mm, rearward of a vertical plane thatintersects the ear canals. In some configurations, the top portioncomprises a first segment 392 and a second segment 394 with the firstsegment 392 and the second segment 394 combining to form the topportion. The first segment 394 extends upward from an apex of the leftarched portion 386 while the second segment 392 extends upward from anapex of the right arched portion 388. Preferably, the top portion isformed of a self-supporting and semi-rigid material. In someconfigurations, the top portion does not include any backing, includinga soft padded backing layer.

Each of the upper and lower arms 284, 286 comprises a slot 292, 290 neareach arm end. Each slot is configured to receive straps 260 from themask assembly 102, as shown in FIG. 2. In addition, the portion 398 ofthe semi-rigid headgear 380 covered by straps 260 is thinner than thecorresponding arm 284, 286 in order to accommodate the thickness of thestrap 260. For example, as shown in FIGS. 47 and 48, the semi-rigidheadgear portion 398 is thinner than the arm 286. The portion 398 isdimensioned such that when the strap 260 is inserted into the slot 290and tensioned, its thickness will not extend beyond the arm 286. Bymaintaining the strap 260 and portion 398 thickness less than the arm286 thickness, the strap 260 does not irritate the user when worn.

In addition, the upper arms 284 are configured to extend downward from alocation above the user's ear such that the adjustable top straps 260extend no closer than about 10 mm to the user's eye when worn. The lowerarm 286 is configured to be located off of the user's neck when the headis tilted up and down, and the termination point of the lower arm 286 islocated generally below the user's ears so that the lower strap asattached to the lower arm 286 angles upwards from the termination point290 to the mask assembly 120. In such a configuration, as illustrated inFIGS. 49 and 50, the lower straps and the upper straps form a triangle,and the space between the lower straps and the upper straps on the maskis smaller than the space between the lower straps and the upper strapson the headgear, thereby stabilizing the mask assembly 120 againstupward and downward movements.

With reference to FIG. 26, the elbow 222 connects to a conduit 300through a disconnectable swivel assembly 302. As shown in the sectionview of FIG. 52, the elbow 222 comprises a stem 304 that comprises aninner wall 306 at the base. The inner wall 306 comprises a recess 308.

A sleeve 310 comprises a flange 312 that is received within the recess308. The sleeve 310 can be secured into position within the elbow 222using any suitable technique. The sleeve 310 comprises a generallycylindrical outer wall 314. The flange 312 comprises a section thatextends outward to connect to a lever 316. Preferably, the flange 312and the lever 316 are integrally formed. With reference to FIG. 53, thelever 316 includes a lower inwardly extending catch 320 and is capableof pivoting about the section that connects the lever 316 to the flange312. Thus, pressing inward on an upper portion 322 of the lever 316results in the catch 320 moving away from the generally cylindricalouter wall 314 of the sleeve 310.

A swivel 330 comprises a generally cylindrical inner wall 332. The innerwall 332 slides over the outer wall 314 of the sleeve 310 such that asliding fit results between the swivel 330 and the sleeve 310. An upperportion 334 comprises a shoulder 336. The catch 320 of the lever 316 cansecure the swivel 330 in axial position on the sleeve 310 by engagingwith the shoulder 336. When the upper portion 322 of the lever 316 isdepressed, the catch 320 moves away from the shoulder 336, which allowsthe swivel 330 to be removed from the sleeve 310.

A flap 350 can be mounted between the stem 304 and the sleeve 310. Inthe illustrated configuration, the flap 350 extends into a flow channel352 from a base 354 that is sandwiched between the stem 304 and thesleeve 310. The flap 350 can pivot upward (as shown in FIG. 52, seearrow P) about an axis X (see FIG. 53) away from the sleeve 310 suchthat flow from a positive pressure generator can continue generallyunobstructed to the user through the interface 100. The flap 350 pivotsdownward into contact with the sleeve 310 to seal the flow channel 352in the event that the positive pressure source stops providing apressurized flow of air. In some configurations, the flap 350 will notfully contact the sleeve 310. In some configurations, the flap 350 willnot seal the channel 352 when in the down position.

With reference to FIG. 53, a port 360 is defined through the elbow 222at a location above the flap 350. The port 360 preferably is positionedalong a portion of the elbow 222 that is in the vicinity of the axis X.In some configurations, the port 360 is positioned to be substantiallyshielded by the flap 350 from an inspiratory flow of air. In otherwords, as the air pivots the flap 350 away from the sleeve 310, the flap350 is moved into a position that at least partially or completelycovers the port 360.

In some configurations, the port 360 extends through a wall of the elbow222 that comprises a generally planar inner wall 362. The generallyplanar inner wall 362 helps the flap 350 to generally seal the port 360when the flap is moved upward away from the flange 312 of the sleeve310.

In some configurations, the lever 316 overlies a majority of the port360 such that the port 360 is generally obscured from view. As shown inFIG. 52, however, a gap 364 preferably surrounds at least a portion ofthe lever 316 such that a relatively free flow of air can pass throughthe port 360 when the flap 350 does not overly the port 360. Inaddition, in some configurations, the port 360 and the lever 316 arepositioned on a same side of the elbow 222 as an opening 370 definedwithin the ball end 220, which opening is positioned within the maskassembly 102 when the connection port assembly 104 is assembled to themask assembly 102. Advantageously, such a positioning places the port360 in a position on the elbow 222 that faces the user. Such a locationfurther obscures the port 360 from view during use, which results in amore aesthetically pleasing configuration. Moreover, because flowthrough the port 360 will be very infrequent, having the port 360disposed toward the user will not cause any significant discomfort forthe user.

While not shown, the elbow 222 also can comprise one or more bias flowvent holes. The bias flow vent holes preferably are positioned in aforwardly directed orientation such that any bias flow does not directlyimpinge upon the user.

Another configuration of an elbow assembly 302 is illustrated in FIGS.54-57. The elbow assembly 302 comprises an elbow 222, a sleeve, 310,and/or a swivel 330, as shown in FIG. 55. In some configurations, theelbow assembly 302 only includes the elbow 222 and sleeve and omits theswivel 330. The swivel may be permanently or removably attached to thesleeve 310 and elbow 222; in some configuration, the swivel 330 isintegrally formed with the end of the delivery conduit. A flap 350 ispositioned over the sleeve 310 such that it at least partially obstructsthe sleeve's flow channel 352. The elbow assembly 302 functionssimilarly to the elbow assembly 302 of FIGS. 26, 27, and 51-53; however,the elbow assembly 302 of FIGS. 54-57 provides the additional benefit ofdirecting gases away from the patient when the flap 350 drops to itsclosed position (as shown in FIGS. 56 and 57).

With reference to FIG. 55, the sleeve 310 preferably comprises two ormore cut out regions or recesses 356. The recesses 356 can have anysuitable shape and, in the illustrated configuration, the recesses 356comprise a semicircular configuration that extends upward into thesleeve 310. The sleeve 310 also comprises at least one bump 357, andpreferably two or more bumps 357. Preferably, each of the bumps 357extends around an arc of about 70 degrees. More preferably, each of thebumps 357 is generally centered between two recesses 356 and each of thebumps 357 extends about 70 degrees around an outer surface of the sleeve310.

The swivel 330 preferably is generally cylindrical in configuration. Asshown in FIG. 55, the swivel 330 has an inwardly extending ridge 358.The ridge 358 preferably encircles the entire inner surface. In someconfigurations, the ridge 358 can be interrupted. Preferably, however,the ridge 358 does not have any interruptions large enough toaccommodate the entire bump 357 such that the ridge 358 and the bump 357can cooperate to keep the swivel 330 mounted over the sleeve 310. Whenassembling the swivel 330 to the sleeve 310, the recesses 216 allow thebumps 220 to deflect inward such that the bumps 357 can slide over theridge 358 and then snap back outward to secure the bumps 357 under theridge 358.

The elbow 222 comprises openings 420 at its sides that are in fluidcommunication with an air venting channel 422. The air venting channel422 is formed by the spacing between the elbow's inner and outer walls362, 424, as shown in FIGS. 56 and 57.

When the flap 350 drops to its closed position, as shown in FIGS. 56 and57, air exhaled from the user enters opening 370 of the elbow 222. Theexhalation flows through the port 360 in the elbow's inner wall 362, andthrough the venting channel 422 until it exits the elbow 222 via theopening 420.

The configuration of FIGS. 54-57 provides a reduced overall length andimproves product aesthetic by eliminating an unsightly hole positionedat the front of the elbow 222. In addition, the configuration of FIGS.54-57 and improves patient comfort by preventing air from being directedtowards the user. Instead, openings 420 direct air flow out of the sidesof the elbow 222 and away from the patient.

Although the present invention has been described in terms of a certainembodiment, other embodiments apparent to those of ordinary skill in theart also are within the scope of this invention. Thus, various changesand modifications may be made without departing from the spirit andscope of the invention. For instance, various components may berepositioned as desired. Moreover, not all of the features, aspects andadvantages are necessarily required to practice the present invention.Accordingly, the scope of the present invention is intended to bedefined only by the claims that follow.

What is claimed is:
 1. A mask assembly for use with a respiratoryinterface for providing respiratory gas to a user in use, including nosetabs providing additional lateral compressive forces against a user'snose for nose bridge support and to reduce air leakage, the maskassembly comprising: a mask base comprising a mask base wall made of afirst material, the mask base wall having a distal portion defining arespiratory gases inlet, the mask base wall extending from the distalportion, around the respiratory gases inlet and proximally toward a userin use, to a proximal peripheral end of the mask base wall, the maskbase wall having an inner mask base wall surface; a seal member made ofa second material that is more flexible than the first material, theseal member having a distal peripheral end, a sidewall portion, a facecontacting wall portion, and a proximal end of the face contacting wallportion, the distal peripheral end being connected to the proximalperipheral end of the mask base wall, the sidewall portion extendingfrom the distal peripheral end of the seal member proximally toward auser in use, to the face contacting wall portion of the seal member, theproximal end of the face contacting wall portion being disposed radiallyinwardly from the sidewall portion, the sidewall portion having asidewall outer surface facing radially outwardly and the face contactingwall portion having a face contacting wall outer surface facing toward auser in use, wherein the sidewall portion and the face contacting wallportion have a sidewall inner surface and a face contacting wall innersurface, respectively, and wherein the sidewall portion, the facecontacting wall portion, and the mask base wall define a mask assemblysidewall, and wherein the sidewall inner surface, the face contactingwall inner surface, and the inner mask base wall surface define aninwardly facing surface of the mask assembly, the mask assembly sidewallcomprising a silicone connector portion; a tab integrally formed withthe seal member, the tab having a proximal end portion and a distal endportion, the proximal end portion of the tab extending from the facecontacting wall portion to the distal end portion of the tab which issealed to the mask assembly sidewall with the silicone connectorportion, the silicone connector portion being disposed at a firstlocation that is disposed distally from the face contacting wallportion, the tab including first and second side edges extending fromthe proximal end portion to the distal end portion, the tab forming afirst loop with the inwardly facing surface of the mask assembly andconfigured to press at least part of the face contacting wall outersurface laterally against a first side of a user's nose in use. Carrythis change through
 2. The mask assembly according to claim 1, whereinthe distal end portion of the tab is adjustably connected to thesilicone connector portion.
 3. The mask assembly according to claim 1,wherein the silicone connector portion comprises a wider portion and anarrower portion, the narrower portion being closer to the distal endportion of the tab than the wider portion.
 4. A mask assembly for usewith a respiratory interface for providing respiratory gas to a user,the mask assembly comprising: a mask base comprising a mask base wall,the mask base wall having a distal portion defining a respiratory gasesinlet, the mask base wall extending from the distal portion to aperipheral edge of the mask base wall, the mask base wall having aninner mask base wall surface; a seal member having a distal peripheraledge, a sidewall portion, and a face contacting wall portion, the distalperipheral edge being connected to the peripheral edge of the mask basewall, the sidewall portion extending from the distal peripheral edge ofthe seal member proximally toward a user in use; wherein the mask basewall, the sidewall portion, and the face contacting wall portion definea mask assembly sidewall, the mask assembly sidewall comprising aconnector portion of a flexible material; and a tab having a proximalend portion and a distal end portion, the proximal end portion of thetab extending from the face contacting wall portion to the distal endportion of the tab which is coupled with the connector portion at asecond location that is disposed distally from the proximal end portionsuch that the tab forms a first loop with the mask assembly sidewall. 5.The mask assembly according to claim 4, wherein the tab includes firstand second side edges extending from the proximal end portion to thedistal end portion.
 6. The mask assembly according to claim 4, whereinthe mask base wall is made of a first material, the seal member and theconnector portion being more flexible than the first material.
 7. Themask assembly according to claim 4, wherein the connector portioncomprises a wider portion and a narrower portion, the narrower portionbeing closer to the distal end portion of the tab than the widerportion.
 8. The mask assembly according to claim 4, wherein the tab isintegrally formed with the seal member and tapers toward the distal endportion of the tab.
 9. The mask assembly according to claim 4, whereinthe tab is configured to press at least part of an outer surface of theface contacting wall portion laterally against a first lateral side of auser's nose in use.
 10. The mask assembly according to claim 4, whereinthe distal end portion of the tab is sealed to the connector portion.11. The mask assembly according to claim 4, wherein the connectorportion is adjacent to the mask base.
 12. The mask assembly according toclaim 4, wherein the distal end portion of the tab is adjustablyconnected to the connector portion
 13. A mask seal assembly for use witha respiratory interface for providing respiratory gas to a user, themask seal assembly comprising: a mask base comprising a distal inlet anda proximal peripheral end; a seal member having a sidewall portion and aface contacting wall portion, the sidewall portion being connected tothe proximal peripheral end of the mask base, wherein the mask base andseal member define a mask seal assembly sidewall comprising a flexibleconnector portion; and a tab comprising a first end portion and a secondend portion, the first end portion extending from a first proximallocation of the face contacting wall portion and the second end portionconnected to the flexible connector portion disposed at a first distallocation of the mask seal assembly sidewall that is disposed distallyfrom the first proximal location, wherein the tab includes first andsecond side edges extending from the first proximal location to thefirst distal location and wherein the tab forms a first loop with themask seal assembly sidewall.
 14. The mask seal assembly according toclaim 13, wherein the second end portion of the tab is sealed to theflexible connector portion.
 15. The mask seal assembly according toclaim 13, wherein the flexible connector portion comprises a widerportion and a narrower portion, the narrower portion being closer to thesecond end portion of the tab than the wider portion.
 16. The mask sealassembly according to claim 13, wherein the sidewall portion comprises asidewall outer surface facing radially outwardly and the face contactingwall portion comprises a face contacting wall outer surface facingtoward a user in use.
 17. The mask seal assembly according to claim 13,wherein the tab is integrally formed with the seal member.
 18. The maskseal assembly according to claim 13, wherein the tab tapers toward thefirst distal location and is configured to press at least part of anouter surface of the face contacting wall portion laterally against afirst side of a user's nose in use.
 19. The mask seal assembly accordingto claim 18, wherein the flexible connector portion is silicone.
 20. Themask seal assembly according to claim 13, wherein the second end portionof the tab is adjustably connected to the flexible connector portion.